Industrial internet of things: What does it mean for the bioprocess industries?

Industrial Internet of Things (IIoT) is a system of interconnected devices that, via the use of various technologies, such as soft sensors, cloud computing, data analytics, machine learning and artificial intelligence, provides realtime insight into the operations of any industrial process from product conceptualisation, process optimisation and manufacturing to the supply chain. IIoT enables wide-scope data collection and utilisation, and reduces errors, increases efficiency, and provides an improved understanding of the process in return. While this novel solution is the pillar of Industry 4.0, the inherent operational complexity of bioprocessing arising from the involvement of living systems or their components in manufacturing renders the sector a challenging one for the implementation of IIoT. A large segment of the industry comprises the manufacturing of biopharmaceuticals and advanced therapies, some of the most valuable biotechnological products available, which undergo tight regulatory evaluations and scrutinization from product conceptualisation to patient delivery. Extensive process understanding is what biopharmaceutical industry strives for, however, the complexity of transition into a new mode of operation, potential misalignment of priorities, the need for substantial investments to facilitate transition, the limitations imposed by the downtime required for transition and the essentiality of regulatory support, render it challenging for the industry to adopt IIoT solutions to integrate with biomanufacturing operations. There is currently a need for universal solutions that would streamline the implementation of IIoT and overcome the widespread reluctance observed in the sector, which will recommend accessible implementation strategies, effective employee training and offer valuable insights in return to advance any processing and manufacturing operation within their respective regulatory frameworks.